Twyneo (3% microencapsulated benzoyl peroxide/0.1% microencapsulated tretinoin) / Sol-Gel, Viatris - LARVOL DELTA

Individual sol-gel microencapsulation of benzoyl peroxide and tretinoin enables controlled release onto the skin. (PubMed, Heliyon) - "The active ingredients are released through small channels in the silica shell, gradually releasing the active ingredients to the skin. This study describes the stability and release profiles of encapsulated tretinoin and encapsulated benzoyl peroxide from the silica shell in physiologically relevant conditions and provides differentiation from traditional formulations."

Journal • Acne Vulgaris • Dermatology • Rosacea

New Topical Combination Formulas in Dermatology (INDERCOS 2024) - "In a clinical study including 60 patients with mild-moderate facial acne the efficacy and safety of Tazarotene 0.1% Plus Clindamycin 1% Gel Versus Adapalene 0.1% Plus Clindamycin 1% Gel was examined...In markets, Epiduo fort gel including 0.3% adapalene and 2.5% BPO is also available for mild-moderate acne vulgaris...Besides, Twyneo (a fixed dose comb...For the use of accompanying disorders with acne vulgaris such as acne and melasma the triple combination including Retinoic acid 0.025, Clindamycin 2%, Hydroquinone 4%; for acne and hirsutism double combination of Clindamycin 2% and Eflornithine 11.5%; for acne and seborrheic dermatitis Clotrimazole 1% and Erythromycin 2% are all available...Numerous products such as thermal waters and a variety of creams pharmaceutical compounding offers the advantage of combining with metronidazole or topical antiirritants (e.g., enoxolone, alpha bisabolol) and venotonic agents to prevent disease progression.For sensitive skin and..."

Acne Vulgaris • Alopecia • Dermatitis • Dermatology • Dermatopathology • Immunology • Infectious Disease • Obesity • Psoriasis • Rosacea • Seborrheic Dermatitis

Drugs for acne. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Acne Vulgaris

Real-World Adverse Events Associated with Encapsulated Benzoyl Peroxide/Tretinoin, 3%/0.1%, and Encapsulated Benzoyl Peroxide, 5. (PubMed, Dermatol Ther (Heidelb)) - "The adverse events were generally mild and restricted to local irritation, pruritus, burning sensation, and erythema. The real-world incidence and type of adverse events reported by the community for encapsulated benzoyl peroxide/tretinoin, 3%/0.1%, and benzoyl peroxide, 5%, were consistent with the safety and tolerability findings from the phase III clinical studies of these treatments."

Adverse events • Journal • Real-world • Real-world evidence • Acne Vulgaris • Dermatology • Pruritus • Rosacea

Silica-based microencapsulation used in topical dermatologic applications. (PubMed, Arch Dermatol Res) - "The second formulation contains silica microencapsulated 5.0% BPO topical cream to treat inflammatory rosacea lesions in adults. Both formulations use the same amorphous silica sol-gel microencapsulation technology to improve formulation stability and skin compatibility parameters."

Journal • Review • Acne Vulgaris • Dermatology • Pediatrics • Rosacea

Results of Two Phase 1 Studies of Encapsulated Benzoyl Peroxide/Tretinoin, 3%/0.1%: An Evaluation of the Phototoxic and Photoallergic Potential (WCD 2023) - "In both studies, there was no evidence of phototoxicity or photoallergy for E-BPO/T or vehicle"

P1 data • Acne Vulgaris • Dermatology • Immunology • Pediatrics

Results From Two Phase 1 Skin Irritation and Sensitization Safety Studies of Encapsulated Benzoyl Peroxide/Tretinoin, 3%/0.1% (WCD 2023) - "Microencapsulation results in a slower release of active drug to the skin after application, which likely contributes to the improved tolerability of E-BPO/T. Under exaggerated conditions of the studies, E-BPO/T was considered moderately irritating, whereas the vehicle was considered not irritating. No subjects discontinued the study due to irritation, and there were no reported adverse events."

Clinical • P1 data • Acne Vulgaris • Dermatology

Re-Formulating the Old Tretinoin: Unique Microencapsulated Tretinoin with Microencapsulated Benzoyl Peroxide Combination Product for Acne Vulgaris (WCD 2023) - "Unique microencapsulation technology enables combining BPO 3% and tretinoin 0.1% into one cream for concurrent use of both actives for acne treatment with a manageable tolerability profile"

Acne Vulgaris • Dermatology • Pruritus

Fixed-Dose Combination Encapsulated Benzoyl Peroxide 3% Plus Encapsulated Tretinoin 0.1% Cream for Treatment of Acne Vulgaris (WCD 2023) - "E-BPO/T achieved statistically superior results to vehicle for IGA success, IL, and NIL reductions from baseline to Week 12 with a favorable safety and tolerability profile"

Acne Vulgaris • Dermatology • Pain

Efficacy and Safety of Microencapsulated Benzoyl Peroxide and Microencapsulated Tretinoin for the Treatment of Acne Vulgaris: Results from Two Phase 3 Double-Blind, Randomized, Vehicle-Controlled Studies. (PubMed, J Am Acad Dermatol) - "E-BPO/T provided statistically significant and clinically relevant improvements in IGA and inflammatory and noninflammatory lesion counts and was well tolerated in subjects with moderate to severe acne."

Journal • P3 data • Acne Vulgaris • Dermatology

Impact of Topical Vehicles and Cutaneous Delivery Technologies on Patient Adherence and Treatment Outcomes in Acne and Rosacea. (PubMed, J Clin Aesthet Dermatol) - "Further research is needed to fully highlight the impact of patient satisfaction and modern topical formulations on adherence and treatment outcomes. Drug microencapsulation is a delivery technology that has enabled development of a topical fixed-dose combination of benzoyl peroxide and tretinoin preventing the oxidation of tretinoin by benzoyl peroxide and improving the tolerability of the active ingredients."

Adherence • Journal • Review • Acne Vulgaris • Dermatology • Rosacea

Tretinoin 0.1% and Benzoyl Peroxide 3% Cream for the Treatment of Facial Acne Vulgaris. (PubMed, Ann Pharmacother) - "A systematic review of the literature was performed using the terms Twyneo OR tretinoin and benzoyl peroxide OR S6G5T-3 in MEDLINE (PubMed) and EMBASE. Tretinoin 0.1%-benzoyl peroxide 3% cream is safe and effective for the treatment of moderate-to-severe acne. Long-term trial data on efficacy and tolerability are not yet available."

Clinical • Journal • Review • Acne Vulgaris • Dermatology • Pain

Tretinoin/benzoyl peroxide cream (Twyneo) for acne. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Acne Vulgaris

"$SLGL Sol-Gel Technologies Announces the Commercial Availability of TWYNEO® https://t.co/QRQTMKtNzF" (@stock_titan)

PT011 - Groundbreaking acne treatment: TWYNEO Cream dermatology’s only combination .1% tretinoin and 3% BPO for moderate to severe acne vulgaris (AAD 2022) - "Description Exhibiting Company: Galderma Laboratories, LP Theater 3: Booth 3571"

Acne Vulgaris • Dermatology

Groundbreaking acne treatment: TWYNEO Cream dermatology’s only combination .1% tretinoin and 3% BPO for moderate to severe acne vulgaris (AAD 2022) - No abstract available

Acne Vulgaris • Dermatology

"$SLGL Sol-Gel Technologies Announces FDA Approval of TWYNEO® https://t.co/pMCX5X8P0i #fdaapproval" (@stock_titan)

FDA event

"$SLGL FDA Accecpts NDA for Twyneo for the Treatment of Acne Vulgaris. PDUFA 08/01/21" (@BioStocks)

NDA • PDUFA date • Acne Vulgaris • Dermatology

Newly added product (GlobeNewswire) - P3, Dermatology

Pipeline update